Rcadia Medical Imaging Ltd. (Haifa, IL)

It is feasible to perform a triple-rule-out procedure by using the images. The data from the imaging include the following: a heart the pulmonary artery, the ascending aorta and thoraco abdominal region. The heart region as well as an ascending aorta object as well as an abdominal aorta aorta object and a left main pulmonary artery object, and an artery in the right main object are identified from the imaging data. The identified heart area is analyzed to detect the presence of coronary pathology. The identified ascending aorta object and the abdominal aorta are studied to identify an Aortic dissection. To detect an embolism in the pulmonary system and to detect a pulmonary embolism, the left main pulmonary arterial object as well as the right main pulmonaryartery objects are analysed. The report contains any identified coronary disease, any identified dissection of the aorta, or any pulmonary embolism.

Chest pain is a typical problem in ERs and hospitals. Evaluating and diagnosing chest pain is a huge problem. The ER physician must diagnose and rule out the three most frequent causes of chest pain: aneurysm an embolism pulmonary (PE) or myocardial damage (coronary artery stenosis). This type of triage is referred to in the medical field as “triple rule out.” Up until recently, three distinct types of diagnostic procedures were utilized within the ER to determine the three possible causes. Today, 64-slice multi-detector, computed tomography systems provide visualization of all three vascular beds–the heart, the lungs, and the thoraco-abdominalaorta. The process, known as Computed Tomography (CT) uses x-rays and computerized analysis of images. Beams of x-rays are passed from a rotating device through an area of interest in a patient’s body from several different angles to createcross-sectional images, which are assembled by computer into a three-dimensional (3-D) picture of the area being studied. 64-slice CT has 64 rows of detectors which permit simultaneous scanning of larger areas. 64-slice CT offers a complete collection of images that can be used to assess the causes that could be causing chest pain.

Semi-automatic approaches are used to analysis of CT images. Radiologists must perform an array of procedures that are step-by-step. For example, the radiologist evaluates blood vessels one at one by observing their lumenand looking for pathologies. This can be tedious lengthy, time-consuming, and prone to error. Therefore, it is essential to create a procedure and system that can automatically detect and detects the presence of blood vessel diseases. Additionally, it is needed the method and the system to measure automatically the level obstruction in the blood vessel.

A method and a method for automatic computerized analysis of image data is provided in an exemplary embodiment. In support of the atriple rule out procedure, three types of pathologies can be identified such as an embolism in the pulmonary tract (or aortic dissection), and myocardial injury (or myocardial infarction). The main anatomical structures could be identified. PE detection can be done by studying the pulmonary artery tree. Analyzing the aorta may assist in detecting aneurysms as well as aortic dissection. Analyzing the coronary artery tree by following the coronary blood vessels could assist in the detection of myocardial infarction. Coronary tree branches of the coronary artery tree may further be labeled. To identify the location and/or size of any pathologies, it is possible to trace the analyzed blood vessel. A different example of embodiment could comprise a system and method for showing the pulmonary and coronary arterial tree, and/or the aorta, as well as any pathologies detected through analysis of images. The automated computerized analysis may also incorporate any combination of these features.

A system is described that automates the triple rule-out process using images. The system includes however, it is not limited to an imaging device that is configured to produce imaging data and a processoroperably coupled to the imaging apparatus to receive the generated imaging data. The processor can be used to locate the area of the heart from generated image data. It also examines the ascending orta’s region for the purpose of detecting coronary heart disease.

A device that performs a triple rule-out process using imaging data is shown in an exemplary embodiment. The device includes not only the memory to store imaging data in three dimensions, and the processor can be connected to the memory to receive images. The processor can be utilized to locate the heart’s location based on the generated imaging data. It is also able to look at the heart area for signs of any coronary-related disease.

The method also provides to carry out an automatic triple rule-out procedure by using imaging data. The imaging data includes what follows: a section of the heart of the patient the pulmonary region as well as an ascending region as well as a thoraco abdominal aorta. The heart region as well as an ascending aorta item, an abdominal aorta object, a left main pulmonary artery object as well as a right main arterial pulmonary object are identified from the imaging data. To identify coronary diseases, the identified heart region will be examined. To detect the presence of an aortic dissection abdominal and ascending Aorta structures are scrutinized. The left main pulmonary arterial object and the identifiedright main pulmonary artery object are evaluated to identify an embolism in the pulmonary vein. The report contains any identified coronary disease, identified dissection of the aorta or any embolism in the pulmonary system.

Another exemplary embodiment contains computer-readable instructions that when executed by a processor trigger it to carry out the operations of the method of performing automatic performance a triple rule outprocedure employing image data.

Those skilled in the art can see the drawings and descriptions and the accompanying claims.

Click here to view the patent on USPTO website.

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What is a software medical device?

The FDA refers to functions in software which may include ” Software as a Medical Device” (SaMD) as well as “Software in a Medical Device (SiMD) ), which is software that is integrated into (embedded in) the medical device.

Section 201(h) of the Federal Food Cosmetic, Drug, and Act, 21 U.S.C. 321(h),(1) defines medical devices as apparatus, instrument machines, machines implants, devices, contrivances in vitro regulator, or any other similar or related items, as well as a component or accessory. . . (b) designed for use for the diagnosis of disease or other conditions, or for the cure, mitigation, treatment, or prevention of diseases for animals or humans, or (c) designed to alter the structure or function of the human body or other animals.? Thus, to be considered a medical device, and thus subject to FDA regulation, your software must meet one of two criteria:

  • It must be used in diagnosing and treating patients.
  • It must not be designed to change the structure or function of the body.

If your program is intended to be used by healthcare professionals to diagnose manage, or treat the patient’s information in hospitals and other medical facilities, the FDA will likely view such software to be medical devices that are subject to regulatory review.

Is Your Software a Medical Device?

The FDA’s oversight currently, which looks at functionality more than platform, is designed to ensure that FDA applies its regulatory oversight to medical devices that have capabilities that pose a risk to patient safety. Examples of Device Software and Mobile Medical Apps that FDA is looking at includes

  • Software functions to aid patients suffering from diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD) for instance.) by offering “Skill of the Day” or a behavioral strategy or audio-based messages that users can access when experiencing anxiety.
  • Software functions that offer periodic information on education, reminders, or motivational tips to smokers who are trying to quit, those recovering from addiction, or pregnant women;
  • Software functions that use GPS location data to warn asthmatics of environmental conditions that could trigger asthma symptoms, or to notify an addict (substance users) when near a pre-identified high-risk or high-risk area.
  • Software that uses games and video to help patients to take part in exercise at home.
  • Software functions that ask the user to input the herb or drug they wish to take simultaneously and give information on whether interactions have been observed in the literature and an overview of the type of interaction was described;
  • Software functions that take into account the characteristics of the patient, like gender age, gender, as well as risk factors, to provide individual counseling, screening and preventive advice from established and respected authorities.
  • Software functions that use a list of common signs and symptoms to provide information on when to visit a doctor and what next.
  • Software functions that help users to navigate through a questionnaire regarding symptoms and make a recommendation on the most appropriate medical facility to treat them.
  • These mobile apps allow users to make nurse calls or emergency calls using cell phone or broadband technology.
  • Mobile apps that enable patients or their caregivers to design and send an alert or general emergency message to first responders;
  • Software functions that track the use of medication and offer user-defined reminders to ensure better medication adherence;
  • Software functions that provide patients with a way to access their own health data for example, access to data gathered at a previous visit to the doctor or historical trends and comparison of vital indicators (e.g., body temperature, heart rate, blood pressure or respiration rate);
  • Software functions that aggregate and show patterns in health-related incidents that affect individuals (e.g. hospitalization rates or alert notification rates);
  • Software features let users either manually or electronically input blood pressure data, to share it with e-mail as well as track and track it, and upload it to your personal or electronic health record.
  • Mobile applications that give oral health reminders and tracking tools for those suffering from gum disease;
  • Mobile apps that offer patients suffering from prediabetes with advice or tools to assist them develop better eating habits or increase their physical exercise;
  • Apps that allow users to display images and other messages on mobile devices which are a great option for addicts looking to stop their addiction.
  • Software functions that provide drug-drug interactions and relevant safety information (side effects and interactions between drugs and active ingredient) in a form of a report, based on demographic data (age and gender) and clinical data (current diagnosis), and current medications; and
  • Software functions provide the surgeon with a list of recommended intraocular lens powers and recommended axis of implantation based on the information entered by the surgeon (e.g. an predicted surgically induced astigmatism patient’s axial length , corneal astigmatism before surgery, etc.)
  • Software, typically mobile apps which convert an app on a mobile device into an approved medical device.
  • Software that is connected to mobile platforms by using a sensor or lead to monitor and display the electrical signals generated by the heart (electrocardiograph, ECG).
  • Software that attaches a sensor or other tools to the mobile device to monitor, record and analyze eye movements to diagnose balance disorders
  • Software that inquires about their donor history and their records and then sends those answers to a blood collection facility. This software determines if a donor is eligible to receive blood or any other component.
  • Software that can be connected to an existing device type to regulate its operation, function, or energy source.
  • Software that alters or deactivates the functions of an infusion pumps
  • Software that controls the inflation or deflation of a blood pressure Cuff
  • Software used to calibrate hearing aids and to evaluate the electroacoustic frequencyand the characteristics of sound intensity, and coming from hearing aids, master hearing aids, group hearing aids, or auditory trainers for groups.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

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